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Can a tote bag replace pills? new study tests comfort kit for teens after scoliosis surgery

NCT ID NCT07632833

Symptom relief Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This pilot study will test whether a 'Comfort Tote' filled with items like aromatherapy oils, stress balls, acupressure guides, and a journal can help teens aged 10-21 feel less pain, anxiety, and stress after scoliosis surgery. Half the participants will get a tote with therapeutic items, the other half a non-therapeutic version. The study aims to see if these simple tools can improve recovery and satisfaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Comfort Tote (aromatherapy kit, stress balls, acupressure points, mindfulness exercises, journal)
What this could lead to
If it works, this could provide a simple, drug-free way to help teens manage pain and anxiety after scoliosis surgery.
What could go wrong
This is a very small pilot study (50 people) that hasn't started yet. It's testing a tote bag of comfort items, not a new drug, so the effects may be small or hard to measure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients of all genders, racial, and ethnic groups aged between 10 and 21 that have had been diagnosed with AIS requiring surgical correction with PSF. * Patients must be scheduled to undergo PSF at Morgan Stanley Children's Hospital of NYP. * The patients and their parent(s)/legal guardian(s) must also provide informed consent, for those under 18 years old. * The patient population will include mental health conditions such as anxiety and/or depression and all surgery levels. Exclusion Criteria: * Patients who have had growing rods and revisions, those who have local or systemic infections, those with anemia, cardiovascular diseases, or osteoporosis, and patients with severe medical comorbidities such as neurological or developmental condition that precludes engagement with the Comfort Tote * Patients with two or more chronic conditions (excluding AIS)

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis anxiety anxiety disorder Pain, Postoperative Postoperative Nausea and Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adolescent idiopathic scoliosis Anxiety Postoperative nausea and vomiting Postoperative pain, acute

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.